Director, Regulatory Affairs - , RI | Biospace
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Director, Regulatory Affairs

Amgen

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Location:
, RI
Posted Date:
9/23/2017
Position Type:
Full time
Job Code:
R-43322
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Amgen is searching for a Director, Regulatory Affairs to work in our Global Regulatory Affairs group.  The Director will report to the Executive Director Regulatory Affairs and will work out of our location in Rhode Island.  The Director will organize, facilitate and execute on the development, commercialization and life cycle management of Amgen's manufacturing product portfolio. Group facilitates product development and global registration by developing and

executing regulatory strategies and effective regulatory agency interactions for Manufacturing and Quality throughout product lifecycle. The Director will represent Regulatory to the Senior Management Teams at the manufacturing site(s) and will be a Site Operations Senior Leadership Team Member.

The Director, Regulatory Affairs will build and maintain a team of regulatory professionals with responsibilities for input into the development and implementation of Chemistry Manufacturing and Controls (CMC) regulatory strategies and activities for products manufactured at specific sites. The CMC Site Mfg. Network Team interfaces with site functions (R&D, Quality and Operations), international regulatory representatives, and product (global) regulatory representatives.  The team coordinates the preparation of regulatory documents and identifies issues and factors that may implicate a regulatory strategy or activity. The team is also responsible for supporting facility related activities such as change control and inspections.

Additional responsibilities of the Director, Regulatory Affairs:

  • Develop strategy and be accountable for the execution of manufacturing site related regulatory submissions which support investigational products, commercial products and facility registrations.
  • Accountable for effective change control assessments, filing strategy and risk assessments.
  • Responsible for Team staffing, engagement and budgets.
  • Data Integrity Assessment (DIA) risk management for change strategy.
  • Regulatory oversight for New Product Introductions.
  • Health Authority Inspection support.
  • Non-conformance and Product Action support.
  • Developing and reporting critical metrics.
  • Responsible for Regulatory policy support.

Requirements

Basic Qualifications:

Doctorate degree and 4 years of Operations, Regulatory experience
OR
Master's degree and 8 years of Operations, Regulatory experience
OR
Bachelor's degree and 10 years of Operations, Regulatory experience

AND

4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • CMC-specific regulatory knowledge & experience
  • Pharmaceutical manufacturing/quality knowledge & experience
  • Proven team building & leadership skills
  • Strong interpersonal, collaborative, problem solving and conflict resolution skills
  • Experience in CMC regulatory and manufacturing or quality associated with Biotech industry